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Low Dose Cyclosporin A in Primary Sjögren Syndrome (CYPRESS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01693393
Recruitment Status : Completed
First Posted : September 26, 2012
Last Update Posted : July 29, 2015
Information provided by (Responsible Party):
Eugen Feist, Charite University, Berlin, Germany

Brief Summary:
Sandimmun optoral (Cyclosporin A) is used for the musculoskeletal manifestations of Primary Sjögren Syndrome

Condition or disease Intervention/treatment Phase
Sjögren´s Syndrome Drug: Cyclosporine A Phase 2

Detailed Description:
NSAR are used currently for the treatment of musculoskeletal manifestations at Sjögren Syndrome for the symptomatic release of pain. For therapy-resistant cases drugs also used in Rheumatoid Arthritis are used. For these drugs there is no registration for the treatment of Sjögren Syndrome.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Pilot-Study With Low-dose Sandimmun Optoral (Cyclosporin A) for the Treatment of Primary Sjögren Syndrome
Study Start Date : March 2010
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Cyclosporine A
All patients will receive Cyclosporine A in a dose of 2mg/kg/BW daily for 16 weeks
Drug: Cyclosporine A
Patients will receive Cyclosporine A in a dose of ca. 2mg/kg/BW daily for a 16 week period
Other Name: Sandimmun optoral

Primary Outcome Measures :
  1. Examination of the therapeutic effects (improvement in number of tender, swolen joints, DAS 28) of low dose Cyclosporine A in patients with primary Sjögren Syndrome and articular involvement after a treatment-phase of 16 weeks. [ Time Frame: 16 weeks ]

Secondary Outcome Measures :
  1. Evaluation of the safety (type and number of adverse events and serious adverse events) of low-dose Cyclosporine A in patients with primary Sjögren Syndrome [ Time Frame: 28 weeks ]

Other Outcome Measures:
  1. Study the general health changes and improvement of Sicca-symptoms [ Time Frame: 16 weeks ]
  2. Documentation of improvement of articular manifestations by ultrasound examination [ Time Frame: 16 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of a primary Sjögren´s Syndrome
  • Liver values above 1,5 ULN
  • uncontrolled arterial hypertension
  • intraarticular or systemic use of Glucocorticoids in the last 4 weeks before
  • begin with Study medication

Exclusion Criteria:

  • pre-treatment with Cyclosporine A
  • Infection
  • Neoplasia
  • relevant cardiac, pulmonary, neurologic or psychiatric disease
  • life-Vaccination within 4 weeks before begin with study medication
  • pregnant or breast-feeding
  • weight under 45kg or more than 110kg

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01693393

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Charite Universitätsklinikum Berlin Campus Mitte
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
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Principal Investigator: Eugen Feist, Dr. med. Charite University, Berlin, Germany

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Eugen Feist, PD. Dr. med. Eugen Feist, Charite University, Berlin, Germany Identifier: NCT01693393    
Other Study ID Numbers: COLO400BDE02T
First Posted: September 26, 2012    Key Record Dates
Last Update Posted: July 29, 2015
Last Verified: July 2015
Keywords provided by Eugen Feist, Charite University, Berlin, Germany:
primary Sjogren´s Syndrome
Additional relevant MeSH terms:
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Sjogren's Syndrome
Pathologic Processes
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents
Dermatologic Agents
Antirheumatic Agents